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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024606
Receipt No. R000028313
Scientific Title Effect of vitamin E to basal energy expenditure in NAFLD patients
Date of disclosure of the study information 2017/11/18
Last modified on 2018/09/22

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Basic information
Public title Effect of vitamin E to basal energy expenditure in NAFLD patients
Acronym Effect of vitamin E to basal energy expenditure in NAFLD patients
Scientific Title Effect of vitamin E to basal energy expenditure in NAFLD patients
Scientific Title:Acronym Effect of vitamin E to basal energy expenditure in NAFLD patients
Region
Japan

Condition
Condition Non-alcoholic fatty liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of vitamin E to basal energy expenditure in patients with NAFLD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Beneficial effect of vitamin E to basal energy expenditure for 1 year
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 600 mg of vitamin E for 1year
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were diagnosed as NAFLD
Key exclusion criteria Patients with decompensated-liver cirrhosis
Patients with cancer
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Takikawa
Organization Iwate medical university
Division name Division of Hepatology, Department of Internal medicine
Zip code
Address 19-1 Uchimaru, Morioka, Iwate
TEL 0196515111
Email ytakikaw@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Kakisaka
Organization Iwate medical university
Division name Division of Hepatology, Department of Internal medicine
Zip code
Address 19-1 Uchimaru, Morioka, Iwate
TEL 0196515111
Homepage URL
Email keikaki@iwate-med.ac.jp

Sponsor
Institute Iwate medical university
Institute
Department

Funding Source
Organization Iwate medical university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 H28-71
Org. issuing International ID_1 Iwate medical university
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 22 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 28 Day
Last modified on
2018 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028313

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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